Safety Manual

Table of Contents
Publication Information....................................................................... 2
1:Regulatory Information.......................................................................................4
Intended Use............................................................................................................................................................4
Indications for Use................................................................................................................................................4
Contraindications...................................................................................................................................................5
Prescription Device Statement........................................................................................................................5
Classification of Medical Device.....................................................................................................................5
Recording ECGs during Defibrillation........................................................................................................... 5
Modulating Effects in Digital Systems......................................................................................................... 6
Biocompatibility.......................................................................................................................................................6
Legal Notice..............................................................................................................................................................6
Responsibility of the Manufacturer...............................................................................................................7
Responsibility of the Purchaser/Customer................................................................................................ 7
Warranty Information..........................................................................................................................................7
2:Safety Information............................................................................................... 8
Safety Conventions............................................................................................................................................... 8
Safety Hazards........................................................................................................................................................8
Supplies and Accessories................................................................................................................................12
3:Product and Packaging Information...............................................................13
Hardware Label Locations..............................................................................................................................13
4:Equipment Identification...................................................................................17
Serial Number Label.......................................................................................................................................... 17
Device Address Label and Rating Plate................................................................................................... 17
Symbol Descriptions.......................................................................................................................................... 18
Serial Number Format...................................................................................................................................... 22
Unique Device Identifier...................................................................................................................................22
5:Electromagnetic Compatibility (EMC)............................................................. 23
Guidance and Manufacturer’s Declaration—Electromagnetic Emissions................................24
Guidance and Manufacturer’s Declaration—Electromagnetic Immunity.................................24
Recommended Separation Distances.......................................................................................................27
6:Wireless Regulations......................................................................................... 29
FCC Compliance...................................................................................................................................................29
IC Compliance.......................................................................................................................................................30
RED Information...................................................................................................................................................31